MRI-Guided Prostate Boosts for Prostate Cancer

(BLaStM Trial)

Overseen By Pavel Noa Hechavarria

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of Miami

Must be taking: Anti-androgens

Disqualifiers: Metastasis, Previous pelvic radiotherapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 7.5-8 weeks

164 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this research study is to learn about: 1) improving control of prostate cancer using an extra high dose radiation treatment to the MRI defined high risk tumor areas, in addition to the standard radiation treatment to the rest of the prostate; 2) preserving quality of life by reducing dose to the nearby organs at risk around the prostate; and 3) establishing the relationship of pre- and post-treatment MRI to MRI-directed biopsy results at 2-2.5 years after treatment.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop your current medications. However, if you are on androgen deprivation therapy (ADT), there are specific guidelines you must follow. Please discuss with your doctor for more details.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on androgen deprivation therapy (ADT), there are specific guidelines about its use during the trial.

What data supports the idea that MRI-Guided Prostate Boosts for Prostate Cancer is an effective treatment?

The available research shows that MRI-Guided Prostate Boosts, also known as Stereotactic Ablative Radiotherapy (SABR), is effective for treating prostate cancer, especially for low- and intermediate-risk patients. Studies indicate that SABR can deliver high doses of radiation with precision, similar to brachytherapy, but with fewer side effects. It is also less costly and uses fewer resources compared to other radiation techniques. While SABR is promising for high-risk patients, more data is needed before it can be widely recommended for them outside of clinical trials. Overall, SABR is a promising treatment option for prostate cancer, offering similar effectiveness to traditional methods with potential benefits in cost and side effects. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment MRI-Guided Prostate Boosts for Prostate Cancer?

Research shows that Stereotactic Ablative Body Radiotherapy (SABR), a component of the treatment, is promising for prostate cancer, offering similar effectiveness to brachytherapy with potentially fewer side effects. It is well-tolerated and may delay further treatment needs, although more studies are needed to confirm its long-term benefits. ^{1 2 3 4 5}

What safety data exists for MRI-guided prostate boosts in prostate cancer treatment?

Stereotactic Ablative Radiotherapy (SABR) and its variants, such as Stereotactic Body Radiation Therapy (SBRT), have been studied for prostate cancer treatment. For low- and intermediate-risk patients, SABR has been compared to other radiotherapy methods in large randomized studies, showing it to be feasible and well-tolerated with careful planning. However, for high-risk patients, there is insufficient data to recommend its use outside clinical trials. Studies have shown that SABR is cost-effective and increases system capacity, with promising safety and efficacy results, especially when using advanced systems like CyberKnife. Long-term safety data at higher dose levels is still limited, but SABR is becoming a standard of care for low and intermediate-risk prostate cancer based on positive outcomes from various studies. ^{1 5 6 7 8}

Is MRI-guided prostate boost treatment generally safe for humans?

Stereotactic Ablative Radiotherapy (SABR), a form of MRI-guided prostate boost treatment, has been shown to be well tolerated and feasible for prostate cancer with careful planning, although long-term safety data is limited. ^{1 5 6 7 8}

Is the treatment HEIGHT RT, LEAD RT a promising treatment for prostate cancer?

Yes, HEIGHT RT, LEAD RT, which includes methods like Stereotactic Body Radiation Therapy (SBRT), is promising for treating prostate cancer. Studies show that using MRI guidance with this treatment can lead to better outcomes for patients. It helps doctors target the cancer more precisely, which can improve the effectiveness of the treatment and potentially reduce side effects. ^{9 10 11 12 13}

How is the MRI-Guided Prostate Boosts treatment different from other prostate cancer treatments?

This treatment uses MRI guidance to precisely target prostate cancer with high doses of radiation in fewer sessions, known as stereotactic body radiotherapy (SBRT). This approach can potentially improve treatment accuracy and outcomes compared to traditional methods, which often use more sessions with less precise imaging. ^{9 10 11 12 13}

Research Team

Alan Pollack, MD

Principal Investigator

University of Miami

Eligibility Criteria

Men aged 35-85 with confirmed prostate cancer (adenocarcinoma), T1-T3 stage, Gleason score 6-10, and PSA ≤100 ng/mL. No metastasis or previous radical prostate surgery/radiotherapy. Androgen deprivation therapy is allowed if decided before joining. Participants must be able to consent and willing to complete quality of life assessments.

Inclusion Criteria

My prostate cancer has a Gleason score between 6 and 10.

Suspicious peripheral zone or central gland lesion on MP-MRI

My prostate cancer is confirmed by biopsy.

Exclusion Criteria

I have a history of disorders related to lymphocyte proliferation.

I have a history of cancer.

I do not have any active cancer except for non-spreading skin cancer or early chronic lymphocytic leukemia.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either HEIGHT or LEAD radiotherapy, consisting of 39 fractions over approximately 7.5 to 8 weeks

7.5-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including MRI-directed biopsy results at 2-2.5 years

Up to 5.25 years

Long-term Monitoring

Participants' health-related quality of life and other outcomes are assessed up to 5.25 years post-treatment

Up to 5.25 years

Treatment Details

Interventions

• HEIGHT RT
• LEAD RT

Trial Overview The study tests adding a high dose radiation treatment targeting MRI-defined high-risk tumor areas in the prostate, on top of standard radiation therapy, aiming to control cancer while sparing nearby organs from excess radiation.

Participant Groups

Group I: LEAD RT Group Experimental Treatment 1 Intervention

Participants in this group will receive the Lattice Extreme Ablative Dose (LEAD) radiotherapy. Radiotherapy will begin within two months of fiducial marker placement. The therapy will consist of 39 fractions over approximately 8 weeks.

Group II: HEIGHT RT Group Experimental Treatment 1 Intervention

Participants in this group will receive the Hypofractionated Extended Image-Guided Highly Targeted (HEIGHT) radiotherapy. Radiotherapy will begin within two months of fiducial marker placement. The therapy will consist of 39 fractions over approximately 7 and a half weeks.

HEIGHT RT is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as SBRT for:

• Prostate cancer
• Lung cancer
• Liver cancer
• Pancreatic cancer

Approved in United States as SBRT for:

• Prostate cancer
• Lung cancer
• Liver cancer
• Pancreatic cancer

Approved in Canada as SBRT for:

• Prostate cancer
• Lung cancer
• Liver cancer
• Pancreatic cancer

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Findings from Research

Stereotactic ablative radiotherapy (SABR) has been shown to be feasible and well tolerated for low- and intermediate-risk prostate cancer patients, with promising results from large randomized studies comparing it to conventional treatments.

While SABR shows potential benefits and cost-effectiveness, there is currently insufficient data to recommend its use for high-risk prostate cancer patients outside of clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Ablative Body Radiotherapy for Intermediate- or High-Risk Prostate Cancer. Loblaw, A.[2021]

In a comparison of two treatment methods for high-risk prostate cancer, the SABR boost showed a significantly lower rate of biochemical failure (0%) compared to the HDR-BT boost (18.2%) over a median follow-up of 62 to 72 months, suggesting better efficacy for SABR.

Both treatment methods resulted in similar levels of acute and late toxicity, with minimal impact on quality of life, indicating that SABR may be a safe alternative to HDR-BT for patients undergoing pelvic radiation therapy and androgen deprivation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gantry-Based 5-Fraction Elective Nodal Irradiation in Unfavorable-Risk Prostate Cancer: Outcomes From 2 Prospective Studies Comparing SABR Boost With MR Dose-Painted HDR Brachytherapy Boost. Musunuru, HB., Cheung, P., Vesprini, D., et al.[2022]

Stereotactic ablative body radiation (SABR) is a promising non-invasive treatment for localized prostate cancer, showing similar efficacy to brachytherapy in terms of disease control and lower side effects, making it a potentially safer option.

SABR is also more cost-effective and resource-efficient compared to traditional radiation techniques, but further well-powered studies are needed to confirm its benefits before it can be considered standard care, especially for patients with metastatic disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative body radiotherapy in patients with prostate cancer. Loblaw, A., Liu, S., Cheung, P.[2023]

In a study of 84 low-risk prostate cancer patients treated with Stereotactic Ablative Body Radiotherapy (SABR), long-term quality of life (QOL) outcomes were generally positive, with a median follow-up of 50.8 months, although some patients reported declines in urinary (17.9%), bowel (26.2%), and sexual (37.5%) QOL domains.

Dosimetric factors such as rectal D1cc and penile bulb V35 were identified as significant predictors of worse QOL, highlighting the importance of adhering to strict dosimetric constraints to minimize side effects from treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dosimetric and patient correlates of quality of life after prostate stereotactic ablative radiotherapy. Elias, E., Helou, J., Zhang, L., et al.[2018]

CyberKnife stereotactic ablative radiotherapy (SABR) for treating intermediate- to very-high-risk prostate cancer showed a high 3-year biochemical relapse-free survival rate of 90.2%, indicating its efficacy in managing this condition.

The treatment was well-tolerated, with no patients experiencing severe toxicity (≥ grade 3), and only mild genitourinary and gastrointestinal side effects were reported, suggesting a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy with CyberKnife in the treatment of locally advanced prostate cancer: preliminary results. Fan, CY., Chao, HL., Huang, WY., et al.[2017]

In a study of 66 prostate cancer patients treated with ultra-hypofractionated stereotactic body radiation therapy (SBRT), the treatment demonstrated excellent biochemical control, with a 2-year freedom from biochemical failure (FFBF) rate of 88.4%.

The treatment was associated with low toxicity, as no patients experienced severe (grade ≥3) genitourinary toxicity, and only 13.6% experienced grade 2 toxicities, indicating that SBRT is a safe option for postoperative prostate cancer management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment outcomes of postoperative ultra-hypofractionated stereotactic body radiotherapy in prostate cancer. Ozyigit, G., Onal, C., Beduk Esen, CS., et al.[2023]

Stereotactic ablative radiation (SAbR) at a dose of 45 Gy in 5 fractions shows a promising safety profile for treating localized prostate cancer, with acute urinary and gastrointestinal toxicity rates of 20.4% and 7.3%, respectively, and low rates of late toxicity after 2 years.

The treatment demonstrated excellent efficacy, with a biochemical failure-free survival rate of 100% at 1 year and 98.7% at 2 years, indicating strong disease control outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose-Intensified Stereotactic Ablative Radiation for Localized Prostate Cancer. Chen, L., Gannavarapu, BS., Desai, NB., et al.[2022]

Stereotactic ablative body radiotherapy (SABR) is an advanced treatment that delivers high doses of radiation in fewer sessions while protecting surrounding healthy tissues, making it effective for small tumors in various locations, including the prostate.

SABR is becoming a standard treatment for low and intermediate-risk prostate cancer, supported by research from Sunnybrook and the US prostate SABR consortium, highlighting its efficacy in improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evolution of hypofractionated accelerated radiotherapy for prostate cancer - the sunnybrook experience. Musunuru, HB., Cheung, P., Loblaw, A.[2022]

In a study of 200 prostate cancer patients treated with MR-guided stereotactic body radiotherapy (SBRT), the treatment demonstrated low acute toxicity, with the most common side effect being mild urinary issues in 31% of patients.

The therapy resulted in a significant decrease in Prostate Specific Antigen (PSA) levels in 99% of patients, indicating effective treatment outcomes, while real-time MRI monitoring ensured precise targeting during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome of the first 200 patients with prostate cancer treated with MRI-Linac at Assuta MC. Gelbart Pridan, O., Ben David, MA., Zalmanov, S., et al.[2023]

In a study of 50 prostate cancer patients treated with MRI-guided adaptive radiotherapy (MRgRT) using ultra-hypofractionation, the treatment was well tolerated, with manageable acute genitourinary toxicity rates of 28% for Grade 1 and 36% for Grade 2, and very low gastrointestinal toxicity.

MRgRT allows for real-time tracking and adaptive planning during stereotactic body radiotherapy (SBRT), suggesting it is a promising method for delivering effective treatment with an acceptable safety profile for localized prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance image-guided adaptive stereotactic body radiotherapy for prostate cancer: preliminary results of outcome and toxicity. Ugurluer, G., Atalar, B., Zoto Mustafayev, T., et al.[2022]

In a study of 51 localized prostate cancer patients treated with 1.5T MRgSBRT, the treatment demonstrated low rates of acute and subacute toxicities, with only 11.8% experiencing grade ≥ 2 acute genitourinary (GU) toxicities and 2.0% experiencing grade ≥ 2 acute gastrointestinal (GI) toxicities.

Patient-reported outcomes showed that while urinary, bowel, and hormonal scores decreased initially after treatment, they mostly returned to baseline levels over time, indicating that MRgSBRT is a safe option with manageable side effects for prostate cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

1.5T Magnetic Resonance-Guided Stereotactic Body Radiotherapy for Localized Prostate Cancer: Preliminary Clinical Results of Clinician- and Patient-Reported Outcomes. Poon, DMC., Yuan, J., Wong, OL., et al.[2021]

In a phase 3 randomized clinical trial involving 156 men with localized prostate cancer, MRI-guided stereotactic body radiotherapy (SBRT) significantly reduced the incidence of acute grade 2 or greater genitourinary toxic effects compared to CT guidance (24.4% vs 43.4%; P=0.01).

MRI guidance also led to fewer gastrointestinal toxic effects and better patient-reported outcomes, with a lower percentage of patients experiencing significant increases in urinary symptoms and decreases in bowel quality of life scores at 1 month post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic Resonance Imaging-Guided vs Computed Tomography-Guided Stereotactic Body Radiotherapy for Prostate Cancer: The MIRAGE Randomized Clinical Trial. Kishan, AU., Ma, TM., Lamb, JM., et al.[2023]

In a study involving 20 prostate cancer patients treated with Adaptive Stereotactic Body Radiotherapy (SBRT), the delivered dose was confirmed to be adequate, ensuring that the target area received at least 95% of the prescribed dose while minimizing exposure to surrounding organs.

The study demonstrated that both the daily re-computed doses and cumulative doses were consistent, indicating that the online MRI guidance effectively maintained treatment accuracy despite potential prostate motion during the longer session times.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptive SBRT by 1.5 T MR-linac for prostate cancer: On the accuracy of dose delivery in view of the prolonged session time. Ruggieri, R., Rigo, M., Naccarato, S., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Stereotactic Ablative Body Radiotherapy for Intermediate- or High-Risk Prostate Cancer. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Gantry-Based 5-Fraction Elective Nodal Irradiation in Unfavorable-Risk Prostate Cancer: Outcomes From 2 Prospective Studies Comparing SABR Boost With MR Dose-Painted HDR Brachytherapy Boost. [2022]

3. China pubmed.ncbi.nlm.nih.gov

Stereotactic ablative body radiotherapy in patients with prostate cancer. [2023]

4. Ireland pubmed.ncbi.nlm.nih.gov

Dosimetric and patient correlates of quality of life after prostate stereotactic ablative radiotherapy. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy with CyberKnife in the treatment of locally advanced prostate cancer: preliminary results. [2017]

6. United States pubmed.ncbi.nlm.nih.gov

Treatment outcomes of postoperative ultra-hypofractionated stereotactic body radiotherapy in prostate cancer. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Dose-Intensified Stereotactic Ablative Radiation for Localized Prostate Cancer. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Evolution of hypofractionated accelerated radiotherapy for prostate cancer - the sunnybrook experience. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Outcome of the first 200 patients with prostate cancer treated with MRI-Linac at Assuta MC. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Magnetic resonance image-guided adaptive stereotactic body radiotherapy for prostate cancer: preliminary results of outcome and toxicity. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

1.5T Magnetic Resonance-Guided Stereotactic Body Radiotherapy for Localized Prostate Cancer: Preliminary Clinical Results of Clinician- and Patient-Reported Outcomes. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Magnetic Resonance Imaging-Guided vs Computed Tomography-Guided Stereotactic Body Radiotherapy for Prostate Cancer: The MIRAGE Randomized Clinical Trial. [2023]

13. Italy pubmed.ncbi.nlm.nih.gov

Adaptive SBRT by 1.5 T MR-linac for prostate cancer: On the accuracy of dose delivery in view of the prolonged session time. [2021]